510(k) clearances
Premarket notifications cleared by FDA, newest decision first.
Every 510(k) record MDM has ingested from openFDA. Each clearance page carries the record as FDA published it, the product code it was cleared under, recalls sharing that product code, and a link to the FDA source.
Data as of , the FDA export date. FDA 510(k) database
Clearances by decision year
Last 15 yearsShow the numbers
| Year | Clearances |
|---|---|
| 2012 | 3,135 |
| 2013 | 3,052 |
| 2014 | 3,202 |
| 2015 | 3,020 |
| 2016 | 2,956 |
| 2017 | 3,200 |
| 2018 | 3,062 |
| 2019 | 2,918 |
| 2020 | 2,923 |
| 2021 | 3,023 |
| 2022 | 3,209 |
| 2023 | 3,346 |
| 2024 | 3,129 |
| 2025 | 3,225 |
| 2026 | 2,502 |
| K number | Device | Applicant | Product code | Class | Decision date |
|---|---|---|---|---|---|
| K251528 | syngo.via MI Workflows; Scenium; syngo MBF | Siemens Medical Solutions USA, Inc. | QIH | Class II | |
| K251390 | MTA vpt | Voco GmbH | KIF | Class II | |
| K251291 | Advanix™ Pancreatic Stent and NaviFlex™ Rapid Exchange (RX) Pancreatic Delivery System and Pushers | Boston Scientific Corporation | FGE | Class II | |
| K251080 | IdentiTi II Cervical Interbody System | Alphatec Spine, Inc. | ODP | Class II | |
| K251054 | Hem-o-lok™ PurplePlus™ Large Polymer Ligating Clips | Teleflex Medical | FZP | Class II | |
| K250838 | Denudation Pipettes | Guangzhou PINZHI Medical Device Co., Ltd. | MQH | Class II | |
| K250822 | SOMATOM go.Now; SOMATOM go.Up; SOMATOM go.All; SOMATOM go.Top; SOMATOM go.Sim; SOMATOM go.Open Pro; SOMATOM Pro.Pulse | Siemens Medical Solutions USA, Inc. | JAK | Class II | |
| K250733 | 3DOSE 1ml Syringe | Bimed Teknik Aletler Sanayi & Ticaret A.S. | FMF | Class II | |
| K250448 | Disposable Percutaneous Nephrostomy Dilatation Kit | Shenzhen Trious Medical Technology Co., Ltd | LJE | Unclassified | |
| K250398 | Innovita Flu A/B Antigen Rapid Test | INNOVITA (TANGSHAN) BIOLOGICAL TECHNOLOGY Co., Ltd. | PSZ | Class II | |
| K250286 | Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1) | Magstim Inc. | QPL | Class II | |
| K250165 | Pastelle | WONTECH Co., Ltd. | GEX | Class II | |
| K250105 | Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125) | Aveera Medical | MGZ | Class II | |
| K243826 | SMR Reverse HP Shoulder System | Lima Corporate S.p.A. | PHX | Class II | |
| K243679 | MammoScreen® (4) | Therapixel | QDQ | Class II | |
| K243678 | TalisMann Neuromodulation System | Bioventus LLC | GZF | Class II | |
| K243280 | Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories) | W & H DentalWerk Buermoos GmbH | ERL | Class II | |
| K243255 | URIS Long Implant & Abutments | TruAbutment Inc. | DZE | Class II | |
| K243220 | Onera STS 2 (ONERA STS 2) | Onera B.V. | MNR | Class II | |
| K243207 | BD Vacutainer® Eclipse™ Blood Collection Needle | Becton Dickinson & Co | JKA | Class II | |
| K243123 | IPL Treatment Device (MDSQMC-01) | Medusa (Guangxi)Medical Devices Co., Ltd. | ONF | Class II | |
| K251746 | Pure Impact | Sofwave Medical Ltd. | NGX | Class II | |
| K251720 | OsteoFlo HydroFiber | Surgentec LLC | MQV | Class II | |
| K251490 | 8 mm Assist Cannula; 12 mm Assist Cannula | Intuitive Surgical, Inc. | GCJ | Class II | |
| K251285 | Electric Wheelchair (HG-630) | Zhejiang Automwheel Tech Co., Ltd | ITI | Class II | |
| K251241 | EMPOWR Revision Knee™ (EMPOWR Revision Knee™ Symmetric TT Cones) | Encore Medical, LP | JWH | Class II | |
| K251049 | SurgiLight 1470 Diode Laser System (Model:Halo) | Micro-Energy Medical Technology Co., Ltd. | GEX | Class II | |
| K251031 | Fiber Laser Treatment Systems (HS-232,HS-233) | Shanghai Apolo Medical Technology Co.,Ltd. | ONG | Class II | |
| K250848 | Identity Shoulder System | Zimmer GmbH | MBF | Class II | |
| K250779 | CS-Pro MED | Curative Sound Therapeutics, Inc. | PZL | Class II | |
| K250729 | Power Wheelchair (MOB1107) | VIVE Health LLC | ITI | Class II | |
| K250684 | OPUSWAVE Dual Sensor Imaging System | Terumo Cardiovascular Systems Thi Plant | NQQ | Class II | |
| K250587 | Orthoscan TAU Mini C-Arm | Ziehm-Orthoscan, Inc. | OXO | Class II | |
| K250524 | Mendaera Guidance System | Mendaera, Inc. | ITX | Class II | |
| K250415 | G0 Blood Pressure Monitoring System (G0) | Aktiia SA | DXN | Class II | |
| K250391 | Leksell Gamma Knife® (Elekta Esprit); Leksell Gamma Knife® (Icon™); Leksell Gamma Knife® (Perfexion™) | Elekta Solutions AB | IWB | Class II | |
| K250312 | Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus and Soft Plus Cannula Extra Small | MEDLINE INDUSTRIES, LP - Northfield | BTT | Class II | |
| K250279 | RC-SwiftPrep | Belport Company, Inc., Gingi-Pak | KJJ | Unclassified | |
| K243868 | Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses | Pegavision Corporation | LPL | Class II | |
| K243701 | AuroLase® System | Nanospectra Biosciences, Inc. | GEX | Class II | |
| K243468 | Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103) | Joytech Healthcare Co., Ltd. | CAF | Class II | |
| K243399 | Boehringer Laboratories Liver Retractor | Boehringer Laboratories, LLC | GCJ | Class II | |
| K251933 | SnugFit ASA Extension | Medacta International SA | MBI | Class II | |
| K251719 | Momentum® Posterior Spinal Fixation System | ulrich medical USA Inc | NKB | Class II | |
| K251453 | Arthrex iBalance Partial Knee System | Arthrex GmbH | HSX | Class II | |
| K251212 | Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM) | Access Vascular, Inc | LJS | Class II | |
| K251032 | MiniMed 780G insulin pump | Medtronic, Inc. | QFG | Class II | |
| K250699 | Cure Twist Female 8 Catheter (T8); Cure Twist Female 10 Catheter (T10); Cure Twist Female 12 Catheter (T12); Cure Twist Female 14 Catheter (T14); Cure Twist Female 16 Catheter (T16); Cure Twist Female 8 Catheter Kit with supplies (T8K); Cure Twist Female 10 Catheter Kit with supplies (T10K); Cure Twist Female 12 Catheter Kit with supplies (T12K); Cure Twist Female 14 Catheter Kit with supplies (T14K); Cure Twist Female 16 Catheter Kit with supplies (T16K) | ConvaTec Limited | EZD | Class II | |
| K250221 | StrokeSENS ASPECTS Software Application | Circle Cardiovascular Imaging Inc | POK | Class II | |
| K250204 | Endoscopic Camera System | Shenzhen Sophway Technology Co., Ltd. | FET | Class II |